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FDA 510(k)

NOVA LITE ENDOMYSIAL

K-Number: K980312 · 1998-04-02

ApplicantInova Diagnostics, Inc.
Decision Date1998-04-02
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NOVA LITE ENDOMYSIAL is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-04-02 under 510(k) number K980312. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA LITE ENDOMYSIAL?

NOVA LITE ENDOMYSIAL is a medical device that received FDA 510(k) clearance on 1998-04-02. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K980312.

When did NOVA LITE ENDOMYSIAL receive FDA 510(k) clearance?

NOVA LITE ENDOMYSIAL received FDA 510(k) clearance on 1998-04-02, under 510(k) number K980312.

Who is the listed applicant for NOVA LITE ENDOMYSIAL?

The FDA 510(k) record lists Inova Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVA LITE ENDOMYSIAL?

The FDA product code for NOVA LITE ENDOMYSIAL is DBL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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